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Drudge Retort: The Other Side of the News
Friday, March 28, 2025

Some scientists assigned double the number of new product applications for review. Some deadlines for tobacco products will not be met and the start of new applications have been delayed, scientist says. FDA staff told to shelve other work, including providing early feedback on planned product applications.

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... Some U.S. health regulators who review medical devices and tobacco products for safety and efficacy are struggling to meet deadlines mandated by Congress due to Trump administration layoffs, three scientists working on the projects told Reuters.

On Thursday, the government said it will cut jobs across health agencies, including 3,500 at the U.S. Food and Drug Administration, a follow-on to earlier layoffs.

Two of the scientists who work at the FDA said they had been assigned around double the number of new product applications for review since their colleagues were fired in February. They requested anonymity for fear of professional repercussions.

They said they were instructed to shelve other work, including oversight of other reviewers and providing early feedback on planned product applications before they are submitted for approval review.

One scientist at the FDA's Center for Tobacco Products said the center had delayed starting new applications while staff worked on existing submissions, some with reviews that must be completed within 180 days under U.S. law. Several tobacco-related research projects have also been canceled, he said.

"We have 180 days to complete those (existing) reviews, and we're not going to come anywhere close to that. It's just not going to happen," the scientist said.

The agency's tobacco center is currently reviewing high-profile projects including one from Philip Morris International (PM.N)
, opens new tab that seeks approval for a new iteration of its heated tobacco device IQOS.

A Philip Morris spokesperson said the average wait time for a tobacco-product application is closer to 700 days than 180 days.

The FDA did not respond to a request for comment. ...


#1 | Posted by LampLighter at 2025-03-28 01:15 AM | Reply

Well that was the purpose so....

#2 | Posted by Nixon at 2025-03-28 08:57 AM | Reply

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